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首页> 外文期刊>Journal of pharmacokinetics and biopharmaceutics >Single-dose pharmacokinetics of rifapentine in women.
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Single-dose pharmacokinetics of rifapentine in women.

机译：利福喷丁在女性中的单剂量药代动力学。

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摘要

Gender can be an important variable in the absorption and disposition of some drugs. In this open-label study, 15 healthy, nonsmoking women received a single 600-mg oral dose of rifapentine. Plasma samples were obtained at frequent intervals for up to 72 hr after the dose to determine the pharmacokinetic (PK) parameters of rifapentine and its active metabolite, 25-desacetyl-rifapentine. Peak plasma rifapentine concentrations (Cmax) were observed 5.9 hr after ingestion of the single dose. The mean area under the rifapentine plasma concentration-time curve [AUC(0-->infinity)] was 325 micrograms.hr ml and the mean elimination half-life (t1/2) was 16.3 hr. Plasma concentrations for the 25-desacetyl metabolite peaked at 15.4 hr after the rifapentine dose and declined with a terminal half-life of 17.3 hr. These rifapentine and 25-desacetyl-rifapentine PK data in women were compared to data generated previously in healthy men. Striking similarities in the PK profiles of parent drug and metabolite were found in the two populations. Mean differences in rifapentine CL/F (12%) and t1/2 (2%) were small. The only adverse event reported in the female subjects was discoloration of the urine. Based on these PK and safety data, no dosage adjustments for rifapentine based on gender are recommended.
机译：性别可能是某些药物吸收和处置中的重要变量。在这项开放标签研究中，有15名健康，不吸烟的女性接受了600 mg的利福喷丁单次口服剂量。剂量给药后长达72小时，应定期获取血浆样品，以确定利福喷汀及其活性代谢物25-去乙酰基利福喷汀的药代动力学（PK）参数。摄入单剂量后5.9小时观察到血浆利福喷汀峰值浓度（Cmax）。利福喷丁血浆浓度-时间曲线[AUC（0->无穷大）]下的平均面积为325微克.hr ml，平均消除半衰期（t1 / 2）为16.3 hr。 25-去乙酰基代谢产物的血浆浓度在利福喷丁给药后的15.4小时达到峰值，并以17.3小时的最终半衰期下降。将女性的这些利福喷汀和25-去乙酰基-利福喷汀PK数据与之前在健康男性中产生的数据进行了比较。在这两个人群中发现母体药物和代谢物的PK曲线具有惊人的相似性。利福喷丁CL / F（12％）和t1 / 2（2％）的平均差异很小。在女性受试者中报告的唯一不良事件是尿液变色。根据这些PK和安全性数据，不建议根据性别调整利福喷丁的剂量。

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